The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance

Type 2 Diabetes Clinical Trial

Official title: The Set-Point Study: Evaluating Effects of Changing Glucose Target on Bionic Pancreas Performance

Status Completed

Clinical Trial Summary

The current study is designed to determine the effect on mean glucose, hypoglycemia, glucagon usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal bionic pancreas, and determine whether there is a target at which adequate glycemic control is achieved by an insulin-only bionic pancreas with minimal hypoglycemia.

Clinical Trial Description

We have two specific aims:

Aim 1 is to conduct an outpatient study testing multiple configurations of the bionic pancreas in 24 adult subjects with type 1 diabetes in a random cross-over study versus usual care with an insulin pump. These bionic pancreas configurations include the insulin only BP at 145 mg/dl set point, 130 mg/dl set point, 120 mg/dl set point and 110 mg/dl set point and the bihormonal BP at 130 mg/dl set point, 115 mg/dl set point and 110 mg/dl set point. These arms are all compared to usual care.

Aim 2 is to evaluate the incremental utility of glucagon in the context of automated insulin delivery by the bionic pancreas in preventing hypoglycemia during exercise in the fasted state. The 130 mg/dl set points and 110 mg/dl set points also participate in this fasted exercise visit. These two set points are double blinded, so neither the subjects nor the study staff are aware which arm is bihormonal and which arm is insulin only. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes
• Type 2 Diabetes

• NCT number: NCT02509065
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Completion date: December 2017